European Railway Agency. Application Guide. Rue Marc Lefrancq, 120 BP F Valenciennes Cedex France Application guide Published

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1 European Railway Agency Part 1 of the Reference Document envisaged by Article 27 of the Railway Interoperability Directive Application Guide Reference in ERA: ERA/GUI/XA Version in ERA: 3.0 Date: 30/10/2015 Document elaborated by Document Type: Document Status: European Railway Agency Rue Marc Lefrancq, 120 BP F Valenciennes Cedex France Application guide Published Name Function Released by Richard LOCKETT [RL] Head of Unit Reviewed by Written by (Author) Ny Tiana TOURNIER [NTT] Peter MIHM [PM] Florinel MELINTE [FM] Sorin HANCI [SH] Sarah YOUNG [SY] Head of Authorisation Processes Sector Head of Technical Evaluation Sector Project Officer Project Officer Project Officer Reference: ERA/GUI/XA Version: 3.0 Page 1 of 80

2 0 DOCUMENT INFORMATION 0.1. Amendment Record Table 1: Status of the document. Version Date Author Section Number Modification Description Version /07/2013 ERA Table 1 Table of contents Section 1 Section 4.3 Introduction, References, Terms and Definitions Derogation from TSI, Authorisation of series, Authorisation Template Version /7/2015 XA UNIT Section 5.3 Section 6.3 Annex I Annex II Annex III Authorisation template, Single European Process Principles Loops Templates updated Flowcharts updated Application template added Version 2.2 8/9/2015 Version /9/2015 Version /9/2015 Version /9/2015 Version /10/2015 Version 3.0 Version 3.0 XA UNIT Amended sections FM, SH, RL Section 6 Review of Section 6.2 Paul Hampson SH SH SH,FM Paul Hampson Amended sections Amended sections Amended sections Amended Sections Amended sections UMT revision of comments on updated sections reviewd UMT Proof reading Uploaded for the Cross Acceptance WP No 37 Uploaded for the Cross Acceptance WP No 37 Updated after the Cross Acceptance WP No 37 Proof reading Reference: ERA/GUI/XA Version: 3.0 Page 2 of 80

3 0.2. Table of contents 0 DOCUMENT INFORMATION Amendment Record Table of contents... 3 List of Tables INTRODUCTION REFERENCES ABBREVIATIONS TERMS AND DEFINITIONS PURPOSE AND SCOPE PURPOSE SCOPE TARGET AUDIENCE DESCRIPTION OF: THE REFERENCE DOCUMENT THE NATIONAL REFERENCE DOCUMENTS THE NATIONAL LEGAL FRAMEWORKS HOW TO USE: THE REFERENCE DOCUMENT THE NATIONAL REFERENCE DOCUMENTS THE NATIONAL LEGAL FRAMEWORKS MANAGEMENT OF: THE APPLICATION GUIDE TO THE REFERENCE DOCUMENT THE NATIONAL REFERENCE DOCUMENTS THE NATIONAL LEGAL FRAMEWORKS ANNEX I FORM FOR BACKGROUND INFORMATION ANNEX II STAGES OF THE PROCESS FOR AUTHORISATION ANNEX III - TEMPLATE FOR APPLICATION FOR VEHICLE AUTHORISATION. 60 LIST OF FIGURES Figure 1 The relationship between the Reference Document and national technical rules List of Tables Table 1: Status of the document Table 2: Documents referred to in this application guide Table 3: Abbreviations... 6 Table 4: NTR evaluation criteria (source: Notif-IT) Reference: ERA/GUI/XA Version: 3.0 Page 3 of 80

4 COMMISSION DECISION of 9 March 2011 on the publication and management of the reference document referred to in Article 27(4) of Directive 2008/57/EC of the European Parliament and of the Council on the interoperability of the rail system within the Community (notified under document C(2011) 1536) (Text with EEA relevance) (2011/155/EU) 1 INTRODUCTION This application guide to the Reference Document forms Part 1 of the Reference Document as envisaged by Decision 2011/155/EU of 9 March 2011 on the publication and management of the Reference Document referred to in Article 27(4) of the Interoperability Directive. It is intended to refer to the elements of this Decision, and any other information relevant for the management, understanding and use of the Reference Document. For a better understanding of the European process for vehicle authorisation, it is advised that you read Commission Recommendation 2014/897/EU on matters related to the placing in service and use of structural subsystems and vehicles. Reference: ERA/GUI/XA Version: 3.0 Page 4 of 80

5 1.1 REFERENCES Table 2: Documents referred to in this application guide. Document Reference Title Version Directive 2008/57/EC of the European Parliament and of the As amended by Directive 2008/57/EC Council on the interoperability of the rail system within the Commission Community (Recast) Directive 2013/09/EU Decision 2009/965/EC Decision 2011/155/EU Directive 2004/49/EC Directive 98/34/EC 2014/897/EU COMMISSION DECISION on the Reference Document referred to in Article 27(4) of Directive 2008/57/EC of the European Parliament and of the Council on the interoperability of the rail system within the Community COMMISSION DECISION on the publication and management of the Reference Document referred to in Article 27(4) of Directive 2008/57/EC of the European Parliament and of the Council on the interoperability of the rail system within the Community Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety on the Community's railways and amending Council Directive 95/18/EC on the licensing of railway undertakings and Directive 2001/14/EC on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification (Railway Safety Directive) Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services Commission Decision 2014/897/EC Commission Recommendation of 5 December 2014 on matters related to the placing in service and use of structural subsystems and vehicles under Directives 2008/57/EC and 2004/49/EC of the European Parliament and of the Council CSM Regulation 402/2013 Commission Implementing Regulation (EU) 30 November March 2011 As last amended by Commission Directive 2009/149/EC As last amended by Regulation (EU) No 1025/2012 of the European Parliament and of the Council 5 December /2013/EU No 402/2013 of 30 April 2013 on the common safety method for risk evaluation and assessment and repealing Regulation (EC) No 352/ April 2013 Reference: ERA/GUI/XA Version: 3.0 Page 5 of 80

6 1.2 ABBREVIATIONS Table 3: Abbreviations Abbreviation APS CCS CSM DeBo EC EMC ERATV EN EU GIG IM MS NLF NoBo NR NRD NTR NOTIF-IT NSA RDD RU SMS TEN TSI UIC Definition Authorisation for Placing in Service Control-Command and Signalling Common Safety Method Designated Body European Commission Electromagnetic Compatibility European Register of Authorised Type of Vehicles European Standard European Union Geographical Interest Group Infrastructure Manager Member State National Legal Framework Notified Body National Rule National Reference Document National Technical Rule The database for the notification of national rules (technical and safety) to EC National Safety Authority Reference Document Database Railway Undertaking Safety Management System Trans European Network Technical Specification for Interoperability International Union of Railways Reference: ERA/GUI/XA Version: 3.0 Page 6 of 80

7 1.3 TERMS AND DEFINITIONS Acceptable means of compliance means non-binding opinions issued by the Agency to define ways of establishing compliance with the essential requirements; Acceptable national means ofcompliance means non-binding opinions issued by Member States to define ways of establishing compliance with national rules. It should be published in RDD and it has a non mandatory status. Additional authorisation: The authorisation granted by another Member State after the first authorisation. According to Article 21.5 of the Interoperability Directive a Member State shall clarify if an additional authorisation is needed in the case of TSI or non TSI conform vehicle. Agency: The European Railway Agency Alternative method: Means of proving compliance other than the acceptable national means of compliance (if any exists). For the sake of transparency and to prevent discrimination, the accepted alternative method shall be published in the RDD as an acceptable national means of compliance. Appeal body: A body that is designated to by each Member State under Article 17(3) of Directive2004/49/EC. It could be also the regulatory body set up in accordance with article 30 of Directive 2001/14/EC. Applicant: The role performed by an entity applying for the authorisation of a vehicle type or for placing in service of a vehicle - a role that could be performed by any of the following actors: Keeper, Manufacturer, Railway Undertaking, Infrastructure Manager or other. This does not cover other applicants for EC certificates. Application template : A harmonised, recommended document developed to facilitate the work carried out by an Applicant to obtain an Authorisation for Placing in Service of a Vehicle and/or a Type Authorisation Assessment body (CSM): Role which undertakes assessment(s) to verify, based on evidence, the suitability of a system to fulfil its safety requirements, as defined in Regulation 402/2013/EC. Authorisation Case: Case defined in Section 4.3 of this document. Authorisation file: All documentation necessary for any application for the placing in service of a vehicle under Interoperability Directive including the technical file (including any derogations from requirements, evidence of compliance with equivalent National rules that do not require further checks and evidence of previous authorisations etc.). Conditions and limits of use: Any limitations on intended use specified in the technical file accompanying the EC declaration of verification such as climatic conditions, maximum speed, gradient, etc. Compile: Collect Reference: ERA/GUI/XA Version: 3.0 Page 7 of 80

8 Deemed authorisation: For additional authorisation, in the absence of a decision of the competent National Safety Authority within the prescribed time limits, the placing in service of the vehicle in question shall be deemed to have been authorised after a period of three months starting at the end of these time limits Art 21.8 of Directive 2008/57/EC. Designated Body: Role of a body designated by a Member State pursuant to Article 17(3) of Directive 2008/57/EC for the assessments against National Rules. Fees: Any fee that is required from the applicant during the authorisation process from a national body. It covers administrative fees for the National Safety Authority, the network access fees for on track tests, the authorisation fees, and the assessment fees when the National Safety Authority acts also as Designated Body and Assessment Body (CSM). First authorisation: The authorisation granted by the first Member State for a new vehicle and/ or vehicle type. According to the description given in Articles 22 and 24 of the Interoperability Directive for TSI-conform vehicle and non TSI conform vehicle. Infrastructure Manager: Role of a body responsible for establishing and maintaining railway infrastructure, or a part thereof as defined in Directive 2004/49/EC. Interoperability Directive: Directive 2008/57/EC of the European Parliament and of the Council on the interoperability of the rail system within the Community (Recast). Issuing or granting authorisation: Authorising the placing in service of a vehicle type or a vehicle. It should be noted that there is no authorisation for use in the Directives. The use of a vehicle is carried out under the respective SMSs of a Railway Undertaking or Infrastructure Manager and is not part of the authorisation process. Legal route: The path mandated by EU rules and/or EU recommendations to be followed for the authorisation case. MS agreement: Any agreement between Member States to facilitate the exchange of information and the handling of authorisation processes (first, additional, renewed, simultaneous, etc.). National Legal Framework: The set of rules in a Member State that covers the procedure for the authorisation of placing in service of vehicles. National Safety Rules: Rules required to be notified under Article 8 of Directive 2004/49/EC. National Technical Rules: Rules required to be notified under Article 17 of Directive 2008/57/EC. New authorisation: Authorisation granted by one Member State after the upgrading/renewal of an existing vehicle and/or vehicle type already authorised. According to Article 20 of the Interoperability Directive a new authorisation may need to be granted after the modification of an existing vehicle/ or vehicle type. Notified Body: Role of a body notified by a Member State for the assessments against a given EU legislation. Non mandatory/ Common practice: Practice developed by the European Railway Sector that can be optionally followed during the project. Reference: ERA/GUI/XA Version: 3.0 Page 8 of 80

9 Non TSI conform vehicle: Vehicle which is/was not in conformity with all the relevant TSIs that were in force at the moment of placing in service, including vehicles subject to derogations, or where a significant part of the essential requirements is/was not laid down in one or more TSIs Article 24.1 of the Interoperability Directive. On track tests: Tests that take place on the network for which a National Safety Authority is competent (see art.21.1 of Interoperability Directive) as opposed to rail test facilities (laboratory or closed test track). Pre-engagement: Prior exchanges of information between the applicant, National Safety Authority and other parties where each entity gets confirmation on the feasibility of the project. This stage includes also the requirements freeze if any. Note: The other parties involved can be: Member State for derogation and/or new authorisation (if required, rules applied). Notified Body for review of the arrangements, including the identification/confirmation of TSIs applicable to the project. Designated Body for review of the arrangements, including the identification/confirmation of national rules applicable to the project. Assessment Body (CSM) for review of the arrangements applicable to the project. Infrastructure Manager for the arrangements of on-track tests where required. European Railway Agency as observer Pre-engagement baseline: The document specifying all the aspects concerning the preengagement, including on track test conditions and requirements freeze (if any), for the project. RDD User Role consists of a predefined set of rights to access content, manage content and configure elements within the Reference Document Database (RDD). A registration is needed for RDD user roles providing rights to manage content and configure elements within the Reference Document Database (RDD). Access to information published by the MSs is available without registration. Renewed authorisation: Renewal of a vehicle type authorisation where relevant (changed rules, type validity expiry). Article 26.3 of the Interoperability Directive is applicable only in case of the renewal of a vehicle type authorisation. When there is a design change, (requiring a new EC verification (see conformity assessment modules SB or SH1)) leading to a new vehicle type that falls under the case of a first authorisation (ERA/REP/ /INT - Authorisation of types of vehicles draft final report Version 0.09/16 May 2012). A renewed authorisation is limited to the case where, after assessment against the changed rule(s), it is proven that the vehicle type conforms without any design change. Rules: Mandatory requirements. Reference: ERA/GUI/XA Version: 3.0 Page 9 of 80

10 Safety Directive: Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety on the Community's railways and amending Council Directive 95/18/EC on the licensing of railway undertakings and Directive 2001/14/EC on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification (Railway Safety Directive). Simultaneous application: An applicant requests authorisation from several Member States at the same time (in parallel). Stage: A stage is the flowchart which contains a sub-stage reference symbol, and can be considered the parent of the sub-stage. Subsequent authorisation: Authorisation of a vehicle that conforms to an already authorised vehicle type. According to Article 26.3 of the Interoperability Directive, a vehicle which conforms to a type already authorised in a Member State shall be authorised by that Member State on the basis of a declaration of conformity to this type submitted by the applicant without further checks. Theme: Group of parameters that relates to a given function or part of the vehicle (e.g. Coupling, Wheel, etc.). Time frame: A period calculated from a timeline. Timeline: The exact date where the counter starts for the time frame calculation. TSI conform vehicle: Vehicle which is in conformity with all the relevant TSIs which are in force at the moment of placing in service; provided that a significant part of the essential requirements is laid down in these TSIs and that the relevant TSI on rolling stock has entered into force and is applicable Article 22.1 of the Interoperability Directive. Verification procedure: Covers checks and certification according to requirements from the directives, TSIs and national rules. Reference: ERA/GUI/XA Version: 3.0 Page 10 of 80

11 2 PURPOSE AND SCOPE 2.1 PURPOSE As described in Decision 2011/155/EU on the publication and management of the Reference Document, the purpose of the Reference Document is to facilitate the procedure for authorising the placing in service of vehicles by: (a) listing all the parameters to be checked in connection with the authorisation for placing vehicles in service; (b) identifying all the rules applied by the Member States in conjunction with the authorisation of placing vehicles in service; (c) referencing the rule that applies in respect of each of the parameters to be checked in connection with the authorisation for placing vehicles in service; (d) classifying all rules under group A, B or C in accordance with Section 2 of Annex VII to Interoperability Directive; and (e) outlining the national legal frameworks covering the authorisation for placing vehicles in service, in accordance with Article 1 of Decision 2009/965/EC. In summary it: makes the vehicle authorisation framework transparent; and facilitates cross acceptance. Cross-Acceptance delivers two benefits: checks carried out as part of an authorisation in one Member State are automatically mutually recognised. This means that authorisation in a second Member State invokes checks only if these are strictly necessary for verifying the technical compatibility of the vehicle with the relevant network (recital 42 of the Interoperability Directive); and it reduces the need for a vehicle design to be configured differently for each individual Member State suite of rules. 2.2 SCOPE The Interoperability Directive covers: TSI conform and non TSI conform vehicles; vehicles operating on and off TENs network; new, upgraded and renewed vehicles; and vehicles already operating in one Member State seeking additional authorisation to be placed in service in another Member State. This is also the scope of the Reference Document. The rules contained within the Reference Document are all the rules and processes that are applied by Member States for authorising the placing in service of vehicles in all the different authorisation cases. Where not detailed in full in the TSI, national rules referred to in the TSIs as covering specific cases are included. Reference: ERA/GUI/XA Version: 3.0 Page 11 of 80

12 3 TARGET AUDIENCE The target audience for the Application guide is composed of 3 categories of users of the reference document: Users = Anyone seeking information such as Applicant for APS; MS/NSA; the Agency Manager of the reference document = The Agency Managers of the National reference documents and National legal frameworks = MS/NSA 4 DESCRIPTION OF: 4.1 THE REFERENCE DOCUMENT The legal basis for the Reference Document The responsibility for putting national rules in place rests with the Member States and, unlike the notification to the Commission of national technical rules, the Agency makes no validation of rules in the Reference Document. If a rule is applicable for authorisation it must be published by the Agency. However, the classifications of the equivalence of rules contained within the Reference Document have a legal status because they determine what an NSA carrying out an authorisation may check or call into question. Structure of reference document and general principles Decision 2011/155/EU states that the Reference document shall be structured as follows: Part 1: Application guide: This part shall refer to the elements included in this decision (Decision 2011/155/EU), and any other information relevant for the management, understanding and use of the reference document. Part 2: National Reference Documents: The reference document shall include all national reference documents listing and classifying the national rules, one for each Member State, as referred to in Article 3 of Decision 2011/155/EU. Part 3: Information on National Legal Frameworks: in accordance with Article 1 of Decision 2009/965/EC, the reference document shall include information on the national legal framework applicable to the authorisation of placing in service of vehicles. This part shall be filled in as soon as Member States notify the national measures implementing Interoperability Directive. Reference: ERA/GUI/XA Version: 3.0 Page 12 of 80

13 All three parts of the Reference Document are published on the Agency s website Figure 1 The relationship between the Reference Document and national technical rules Databases The national rules used for vehicle authorisation and the associated data related to the National Reference Documents are stored in two databases: The NOTIF-IT database managed by the European Commission stores the documents containing the national rules, the records of notification of national technical and safety rules and the references of all these rules to TSIs, article 8 of the Safety Directive and the list of parameters, according to the nature and content of the rule. The Reference Document Database (RDD) managed by the Agency. The relation between the Reference Document Database (RDD) and NOTIF-IT To facilitate the notification of rules applied in conjunction to vehicle authorisation and to avoid double data entry, the Commission and the Agency decided to establish a functional relationship between the Reference Document Database and NOTIF-IT. Since version 3.3 of the RDD, the rules which have been uploaded into RDD do not need to be entered separately for notification. The related information can be exported using the application functionality within the RDD to create notifications in NOTIF-IT. In this manner, after export from RDD, the notifier only needs to confirm their notification in NOTIF-IT to start the notification process. Reference: ERA/GUI/XA Version: 3.0 Page 13 of 80

14 Exporting a rule from RDD to NOTIF-IT creates a notification for that rule in NOTIF-IT. When the rule is exported it is locked in RDD (the rule cannot be modified in RDD) and the processing of the notification can start in NOTIF-IT. The changes of status (of the notification of the rule) in NOTIF-IT are reflected in RDD. However, if the rule is updated in NOTIF-IT this is not immediately reflected in RDD. At the end of the processing of the notification in NOTIF-IT, when the notification is accepted, the rule is updated in RDD with the changes performed during the notification in NOTIF-IT, if any. In this moment the rule is unlocked in RDD. When the notification is rejected in NOTIF-IT the notification status of the rule in RDD is changed to rejected and the rule is unlocked in RDD. When unlocked in RDD the rule can again be modified in RDD. Only the mandatory rules published in RDD can be exported to NOTIF-IT. Rules marked as Acceptable National Means of Conformity in RDD, which therefore have a non-mandatory status, cannot be exported to NOTIF-IT. 4.2 THE NATIONAL REFERENCE DOCUMENTS Content of the National Reference Documents The National Reference Documents list all the national technical rules applicable in conjunction with authorisation of railway vehicles. The structure for reference and the listing of these is given by the list of parameters. The current version of the list of parameters is the Annex to Decision 2009/965/EC with the corrigendum published in the Reference Document Application Guide v An update of the list of parameters was voted at the RISC no. 73 of 04/06/2015 and shall enter in force 01/01/2016. In addition, the National Reference Documents shall include the classifications (A, B, C) with other Member States rules. In the case where a Member State has a national technical rule which cannot be addressed to one of the parameters in the list of parameters, the Member State should inform the European Railway Agency. It is to be understood that the National Reference Documents contain an exhaustive list of all the national requirements applied in relation to the authorisation of railway vehicles, cross referenced against the list of parameters. To ensure that transparent and harmonised information on the rules to be applied for vehicle authorisation is publicly available, the Member States must indicate for all parameters: a) The respective national technical rule in force or b) express explicitly that there is no national technical rule. When there is no national technical rule in force for a parameter, this shall be indicated in the National Reference Document as no requirement in addition to applicable TSIs. When the Member State still has to check if there is a requirement for a parameter, it should be indicated as to be investigated. Reference: ERA/GUI/XA Version: 3.0 Page 14 of 80

15 In addition, National Reference Documents should also contain information on acceptable national means of conformity, if any. Criteria for establishing equivalence Each National Reference Document should indicate the classification (A, B, or C), according to Annex VII of the Interoperability Directive 2008/57/EC of other Member States rules for the parameter: Classification A indicates "national rules deemed to be equivalent, to national rules of other Member States" or that the rule is an "international standard"(e.g. EN, UIC leaflet). A rule is deemed to be equivalent when MS1 accepts that if a rule is valid in MS2, then it also meets the essential requirements in MS1. Group C classification "covers rules that are strictly necessary and are associated with technical infrastructure characteristics, in order to ensure safe and interoperable use in the network concerned (e.g loading gauge)". A rule that is classified as C requires additional checks and/or tests to be carried out to prove compliance to MS2 rules. Group B classification "covers all rules that do not fall within the scope of Group A or Group C, or that has not yet been possible to classify in one of these groups". A rule that is classified as B requires additional checks and/or tests to be carried out to prove compliance to MS2 rules. According to art and 25.4 of the Interoperability Directive 2008/57/EC the national safety authority may only carry out verifications on the basis of the national rules relating to Group B or C. Reference: ERA/GUI/XA Version: 3.0 Page 15 of 80

16 4.3 THE NATIONAL LEGAL FRAMEWORKS Structure of the National Legal Framework The structure of the National Legal Framework is based on the Interoperability Directive and Recommendation 2014/897/EU. The aim of the structure of the NLF is to enable easy comparison of NLFs in order to: find the commonalities and the significant differences for the NLFs in the MSs; and compare with the Interoperability Directive and the Recommendation 2014/897/EU. The process for authorisation of placing in service of vehicles is composed of several stages; the stages of the process are described in Annex II of this document. The structure of the NLF is that there is information to be provided for each stage of the process for the related authorisation cases. When choosing the authorisation cases for the process for authorisation of placing in service of vehicles the aim has been to capture all cases that fall under the scope of the Interoperability Directive. Authorisation cases The procedures are similar for several authorisation cases. Therefore, though there were more theoretical authorisation cases, some of them have been merged. In particular, the following two cases have been merged into a single case, except for additional authorisation: TSI conform vehicles; and Non TSI conform vehicles. Effectively, for both cases, there are two sets of requirements that apply: the TSIs and the NTRs. The only difference is that for TSI conform vehicles, the rolling stock TSI applies, whereas for non- TSI conform it might not yet be the case. However, the process is similar even if the requirements may differ. For Non TSI conform vehicles the following applies concerning specific cases and derogations: Specific cases: are applicable for renewal or upgrading of part of the vehicle for which TSIs apply. For additional authorisations specific cases may apply if necessary for technical compatibility with the network. Derogations: are applicable under Article 9 of the Interoperability Directive. It is the responsibility of the concerned MSs to request a derogation to the Commission. The Commission may consult the Agency when assessing complex derogation requests. For derogations falling under Article 9.1 b) d) and f) of the Interoperability Directive, the Reference: ERA/GUI/XA Version: 3.0 Page 16 of 80

17 Commission applies the Regulatory procedure described in Article 29 of the Interoperability Directive. According to Article 26.2 of the Interoperability Directive, when a vehicle is authorised for placing in service its type is automatically authorised whereas when a type of vehicle is authorised there might not be a related vehicle authorised to be placed in service. When only the type is authorised an EC declaration of verification has to be provided (e.g. application of module SD). In the description of the process both authorisation for placing in service of a vehicle and authorisation of a vehicle type are combined where this is not explicitly differentiated. The following cases have been developed and described in the generic flowcharts: First authorisation for vehicle type/vehicle New authorisation for upgraded/renewed vehicle type/vehicle Additional authorisation for vehicle type/vehicle already authorised by an EU MS for TSI and non TSI conform vehicles Renewed authorisation for a type authorisation that is not valid anymore Subsequent authorisations of vehicles conforming to an authorised vehicle type (authorisation of vehicles of the same type) Article of Directive 2008/57/EC mentions Series authorisation. This authorisation case is understood and considered as a combination of a vehicle type authorisation followed by authorisation of a specific set of subsequent identical vehicles by verification of conformity to type. Therefore series authorisation is not described in the Generic flowcharts. Application template The application template is a harmonised document developed to facilitate the work carried out by an Applicant to obtain the Authorisation for Placing in Service (APS) of a Vehicle or a Vehicle Type Authorisation. The application template: Contains the information that needs to be completed by the applicant from the start of the authorisation process until the end; covering all steps of the European Legal Framework. Covers all authorisation cases as defined in chapter 4.3 and simultaneous authorisation. Considers the requirements for the registration of a new vehicle type in ERATV. Can be used as a check list by the Applicant and the National Safety Authority(ies) involved in the APS. Allows for traceability during the whole authorisation process. The template is in annex III. Reference: ERA/GUI/XA Version: 3.0 Page 17 of 80

18 5 HOW TO USE: 5.1 THE REFERENCE DOCUMENT The Reference document contains the rules and processes related to vehicle authorisation that are applied in the EU MSs + Norway and Switzerland. The User will, based on the scope of their authorisation project, identify the rules and processes that are to be used. The Reference document may also be used for the following: Analysis of the level of interoperability already achieved. Analysis of the data contained in the Reference document in order to: o Ensure consistency between TSIs and national rules (e.g. no duplication of requirements). o Reduce the number of national rules where possible. o Replace national rules by TSI requirements where possible. o Close open points in TSIs where possible. o Establish a single European process. o Bring improvement to the vehicle authorisation process. o Simplify the classifications (ABC) between the rules of the MSs Management of authorisation projects. Facilitation of simultaneous authorisation. A procedure for simultaneous authorisation has been developed and included in section 5.3; the use of this procedure is advised but not mandatory. 5.2 THE NATIONAL REFERENCE DOCUMENTS User Until a MS s list of rules has been validated and published in the RDD by the MS, the User can access the list of rules in pdf-format on the Agency s website. In the scope of additional authorisation for placing in service of railway vehicles in accordance with Article 23 and Article 25 of the Interoperability Directive the NSA may not carry out verifications on the basis of national rules classified as A and published in part 2 of the reference document (National Reference Document). In this respect, the criteria checked by a national safety authority may concern only: technical compatibility between the vehicle and the network concerned, including the national rules applicable to the open points needed to ensure such compatibility, the national rules applicable to the specific cases duly identified in the relevant TSIs. Reference: ERA/GUI/XA Version: 3.0 Page 18 of 80

19 Manager of the Reference Document The Manager of the Reference Document ensures the following: Implementation of changes in the structure of the National Reference Documents (NRDs), including any update on the list of parameters. Creation of template reports on request. Support to the Managers of the National Reference Documents (NRDs) in the upload, update and publication of information (rules and classification of rules) related to the NRD of the respective MS. Management of the Reference Document Database. Manager of the National Reference Document The manager of the National Reference Document updates and publishes the national rules and their classifications. These are described in sections 2.4 and 2.5 of the RDD User manual. 5.3 THE NATIONAL LEGAL FRAMEWORKS User Until a MS s National Legal Framework has been validated and published in the RDD by the MS the User can access the National Legal Framework in pdf-format on the Agency s website. The User will be able to view background information, flowcharts, graphical comparison of flowcharts and reports in the RDD. This is described in sections 3.4 and 3.5 of the RDD User manual. Manager of the generic legal framework The manager of the generic legal framework creates the generic flowcharts and background information. This is described in section 5.13 of the RDD User manual. Manager of the National Legal Framework The manager of a National Legal Framework creates their National Legal Framework using the generic flowcharts and background information. This is described in section 4.6 of the RDD User manual. Use of the application template A template for an application for vehicle authorisation, managed by ERA, is presented in Annex III of the this version of the Application Guide. The application should be based on the above mentioned application template which is managed by the applicant and presented to the NSA(s). The application is updated at each stage of the authorisation process indicated in the template: Reference: ERA/GUI/XA Version: 3.0 Page 19 of 80

20 - Pre engagement - Assessment - Authorisation file The Applicant provides the updated application to the NSA which can then be used as a basis for discussions at the different stages of the process. The NSA can use the final version of the application form to deliver the authorisation of this vehicle in a harmonised manner. Advised Procedure for Simultaneous Authorisation Several NSAs may proceed jointly to vehicle authorisation for placing in service. For vehicle authorisations on several MS s networks, the applicant shall apply simultaneously to every concerned NSA according to the respective legislation in force at the date of the application. The NSAs will set up a common organisation that shall contain amongst other things a timetable for implementation. One of the NSAs will be identified to ensure coordination amongst them. In the context of the implementation of the Commission decision 2011/155/EU, the concerned NSAs will agree on the implementation of the related reference documents, in particular for part 2 National Reference Documents and part 3 Information on National Legal Framework. The outputs of the pre-engagement (see part 3 of the Reference Document) on the task sharing and the criteria to apply (e.g. document sharing, document format, language to be used, parameter sharing, non-classified A parameter processing, etc.) are recorded in a report. All participants, including the applicant, shall agree on the pre-engagement baseline (the report noted above). The sharing of A classified parameter verifications between the NSAs will be carried out in agreement with the applicant and can be done by grouping the parameters into defined subject themes (e.g. parking brake related parameters ). Documents necessary for the authorisation for placing in service shall be classified according to the structure of the Common Technical File based on the annex of the Commission Decision 2009/965/EC. For each classified parameter, the applicant will submit the necessary documentation for verification only to the NSA in charge of the assessment of that parameter. The NSAs shall exchange information, which they have respectively assessed, using Conformity certificate(s) related to the A classified parameters. The Conformity certificate is issued by theme and not by parameter. Within every certificate, each assessed parameter shall be clearly identified. These Conformity certificates are sufficient to demonstrate the assessed vehicle s conformity to the related rules including those of the MSs/NSAs who receive them. For B and C classified parameters, the applicant shall submit the required documentation, including DeBo assessment result, to each concerned NSA who will carry out their own assessment according to the national regulations and the agreed pre-engagement baseline. Reference: ERA/GUI/XA Version: 3.0 Page 20 of 80

21 Documents sent to each NSA shall be written in languages according to the agreed preengagement baseline. For parameters classified as A from MS XX to MS YY and C from MS YY to MS XX, the assessments carried out by MS XX will be accepted by MS YY but not vice versa (indicating that there might not be two way equivalence). New assessments shall be performed for modifications on a vehicle that impacts a parameter carrying a certificate. If conformity to the rules is proven; a new certificate shall be issued. Every NSA may issue the authorisation for placing in service of vehicles for its own MS s network when the related authorisation file is complete and accepted. In each MS, the authorisation file will consist of the following points: Documents obtained directly by the MS s NSA for B and C classified parameters. Documents obtained and accepted directly by the NSA itself or the certificate issued by other NSAs for A classified parameters. As each vehicle authorisation for placing in service in a given MS, including additional authorisation, is also valid as vehicle type authorisation in that MS. Every concerned NSA must have at least a copy of all certificates, including the assessment report, established by the notified body in order to ensure the completeness of the file. This is in case of a future further or renewed application from the applicant. Reference: ERA/GUI/XA Version: 3.0 Page 21 of 80

22 6 MANAGEMENT OF: 6.1 THE APPLICATION GUIDE TO THE REFERENCE DOCUMENT This Application guide will be regularly updated in the light of experience as instigated by the Agency with the support of the Cross Acceptance Working Party. 1. Planning At least once per year the Agency will review this Application guide and make any proposal it considers necessary to the Cross Acceptance Working Party. The stakeholders can request reviews if necessary. 2. Updating The Agency is responsible for updating the Application guide. For this update the Agency will take account of any input from the stakeholders. 3. Organisation & coordination of activities The Agency collects any input for the improvement of this Application guide. Stakeholders input can be introduced either via Sector organisations; MSs/NSAs or from individual users. This is done by sending an to The Agency proposal for an update of this Application guide will be posted on the Agency s website at least 1 month before its submission to the Cross Acceptance Working Party. 4. Decision making The decision to have more frequent updates of the Application guide is made by the Cross Acceptance Working Party based on an Agency proposal. The Cross Acceptance Working Party is responsible for: Validating the Agency proposal; and approving the publication of the Application guide. Reference: ERA/GUI/XA Version: 3.0 Page 22 of 80

23 6.2 THE NATIONAL REFERENCE DOCUMENTS The framework to facilitate the authorisation of railway vehicles, considering the requirements expressed by National Technical Rules, is based on three different steps: 1. A common list of parameters to be checked in conjunction with the authorisation of railway vehicles. Current version: Annex to Decision 2009/965/EC with the corrigendum published in the Reference Document Application Guide v An update of the list of parameters was voted at the RISC no. 73 of 04/06/2015 and shall enter in force 01/01/ Collecting the different National Requirements for each parameter concerned and publication of these requirements in the form of the National Reference Document (see Decision 2011/155/EC). 3. Comparing and Classifying, by different MS authorities, the equivalence (A, B, C) of the national rules applied with the rules applied by other MSs (in accordance to Annex VII section 2 of Directive 2008/57/EC). Managing the National Reference Documents (NRD) Decision 2011/155/EU describes the arrangements for the publication and maintenance of the National Reference Documents. To facilitate the access and administration of the information of the National Reference Document, the Agency has launched the Reference Document Database (RDD) which is continuously updated. When the list of rules has been validated and published by the Member State then access to these rules will be redirected from the pdf-format on the Agency s website to the Report page of RDD. NRD maintenance The MS/NSA shall review their National Reference Document to ensure: Consistency with all relevant EU legislation (e.g. TSIs). Consistency with all relevant national legislation. Consistency with the evolution of relevant standards and norms Consistency with the current state of the art (e.g. considering acceptable national mean of compliance) The MS/NSA shall review the information in the National Reference Document regularly to followup on the evolution of the rules, especially in the case of technical development or TSI evolution. To ensure that the information on rules to be applied in conjunction with the authorisation of railway vehicles and their classification of equivalence is up to date, the Agency will provide support to the National Safety Authorities and Member States. The support will consist of Reference: ERA/GUI/XA Version: 3.0 Page 23 of 80

24 assistance with the uploading of information into RDD being provided by the MS/NSA and also various forms of user training (e.g. training meetings, instructional videos etc.) Other actors (i.e. manufacturers, RUs, IMs, associations etc.) may also advise the MS/NSA and/or Agency of a need to update the RDD (e.g. if known rules are missing or other relevant information in the RDD appears to be out of date). In case of receipt of such information, the Agency shall contact the relevant MS/NSA to analyse the reported issue and, where necessary, the MS/NSA shall update the information in the RDD. Evolution of National Reference Documents The draft of new or amended rules shall be notified according to the procedure in Directive 98/34/EC. Conversly, the National Reference Documents shall not be notified according to the procedure in Directive 98/34/EC. A change of a national rule by one Member State may potentially invalidate an A classification of this rule as it might render the vehicle incompatible with the network of the second Member State. It is therefore important for Member States to take great care when changing rules and consider the effect the change may have on the rule s classification by other Member States. It is good practice to discuss such changes at Geographical Interest Group Meetings (GIGs) whilst drafting the changed rule. Cleaning-up of NTRs The Agency will support MSs in verifying whether their rules are aligned to the EU legal framework, facilitating the notification of NTRs to EC 1. To do that, the Agency will establish a service called Cleaning-up of rules. The service is intended to cover the necessary set of activities facilitating the comparison and notification of national technical rules especially in the light of the evolution of TSIs, such as the extension of scope of the TSIs in January It will include the provision of tools such as : - The cross reference table: cross referencing the harmonized list of parameters with the parameters of different TSIs. - The RDD transfer file: to upload updated information of National Reference Documents into RDD. For the scope and purpose of the Reference Document application guide, the cleaning-up of NTRs is limited to the rules applicable in conjunction with the authorisation of railway vehicles. 1 Cf. Project Plan Strategy for the alignment of National Technical Rules to the EU legal framework reference ERA-REP-128 Reference: ERA/GUI/XA Version: 3.0 Page 24 of 80

25 For the evaluation of the National Technical Rule, the evaluation criteria provided in table 4 will apply. To carry out the evaluation, it is necessary to ensure that all mandatory information required for the notification is provided e.g. the open point, specific case or parameter to which the rule applies etc. Table 4: NTR evaluation criteria (source: Notif-IT) NTR EVALUATION CRITERIA 1. Is the NTR in the scope of the Art. 17(3) of the Dir. 2008/57/EC? 2. Does the rule refer to an essential requirement and to a parameter? (Note: for the notification of NON-TSI conform rules, the subsystem & parameter from the list of parameters should be referenced; for notification of rules related to a TSI, the notification must be referenced only to an open point / specific case which will implicitly refers to the parameter and essential requirement) 3. Is the NTR imposed at MS level? 4. Is the NTR applicable to all concerned RU or IM? (i.e. it should not hinder competition) 5. Does the NTR address a NON-TSI conform subsystem? (if the answer is YES proceed to question 8, if it is NO, proceed to question 6) 6. Where the NTR addresses an area of application covered by a TSI - does it refer to an open point/specific case of the TSI concerned? 7. Where the NTR refers to an open point or specific case of the TSI concerned - does it specify only requirements to comply with the open point or specific case of the TSI? (in this case only information to fulfill the OP/SC is accepted, all additional information/requirements will be checked to verify if it undermines the TSI). 8. Does the NTR correctly reference the parameter selected in the notification? 9. Is the text of the NTR accessible/publicly available? 10. Is the information regarding publication or issuing body added to the NTR? Is it exhaustive? 11. For AMENDED rules only: is the AMENDED rule consistent with the rule it amends? (select YES only if the details of the previously registered rule are entered) 12. Is the information regarding the conformity assessment and verification procedures to be carried out for the NTR added to NTR? Is it exhaustive? 13. Is the information regarding the bodies designated to carry out the conformity assessment and verification procedures added to NTR? Is it exhaustive? When completing the information for the respective NTR in RDD, the MSs may transfer, via a dedicated feature in RDD, the rules from RDD to Notif-IT for the notification to EC. The final stage of the cleaning-up process ends with the validation of the rule by EC and publication of the validation in Notif-IT, following which, in the RDD an approved status is indicated. If the rule has been rejected by the EC it is not applicable further and the MS should take appropriate actions e.g. to withdraw or adapt the rule. Reference: ERA/GUI/XA Version: 3.0 Page 25 of 80

26 Update of the list of parameters The Agency proposal for the update of the list of parameters was accepted at RISC 73 on the 04 th of June The new version of the list of parameters shall enter into force on 01/01/2016. This revision aims to improve the understanding and application of the list of parameters and includes: adding/improving the explanation for the parameters, removing obsolete parameters, considerations necessary due to the update of TSIs (e.g. TSI CCS), more detailed specifications, new parameters (for some aspects e.g. EMC). The return of experience from NSAs, GIGs, applicants, other stakeholders and the Agency were used as inputs for the proposal. The new list of parameters will be accompanied by the cross reference table, a document published and managed by the Agency which shows the relationship between the list of parameters and the parameters of different Technical Specifications for Interoperability. The content of the cross reference table will be included in the RDD. Until the new list of parameters has entered into force, the rules and their classification of equivalence will be managed in the RDD based on the list of parameters published in Annex III of the Reference Document Application Guide v After the entry in force of the revised list of parameters: The Agency will implement the updated list of parameters in the RDD. The Agency will coordinate with the MSs/NSAs the migration of the former published National Reference Documents to the updated list of parameters considering the following steps: o Upon agreement with the MS/NSA, the Agency will provide for review by MS/NSA the list of the existing rules published in the RDD in the structure of the new list of parameters. The list will be provided in the form of an RDD upload file (MS Excel). The rules will be allocated to the parameters in the new list automatically wherever possible (when there is a one to one relationship for the parameters ). The MS/NSAs shall revise the list regarding the accuracy of information provided, its up-to-date status and also allocate an adequate parameter to those rules for which a one-to-one relatioship between the previous list of parameters and the updated list could not be provided. Reference: ERA/GUI/XA Version: 3.0 Page 26 of 80